NCT05753345

Brief Summary

The purpose of this study is to explore the feasibility, fidelity and acceptability of an aquatic therapy assessment and intervention for children ages 3-9 with neuromotor deficits such as cerebral palsy. The intervention takes place in a warm water therapy pool, twice a week for ten weeks and targets swim safety skills, upper extremity function and self care participation and performance.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
20mo left

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress68%
Jan 2023Nov 2027

Study Start

First participant enrolled

January 9, 2023

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 3, 2023

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2027

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

4 years

First QC Date

February 3, 2023

Last Update Submit

February 24, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change in Water Orientation Test Alyn (WOTA)

    performance based swim skill assessment

    Baseline, immediately after the intervention

  • Change in Pediatric Evaluation of Disability Index, Computer Adaptive Text (PEDI-CAT)

    parent reported questionnaire regarding child's self care skills

    baseline, immediately after the intervention

  • Change in Quality of Upper Extremity Skills Test (QUEST)

    performance-based assessment of upper extremity skills

    baseline, immediately after intervention

Secondary Outcomes (2)

  • Change in Participation and Environment Measure (PEM-CY)

    baseline, immediately after the intervention

  • Change in Canadian Occupational Performance Measure (COPM)

    baseline, immediately after the intervention

Study Arms (1)

Intervention: aquatic occupational therapy (AquOTic-NM)

EXPERIMENTAL

aquatic occupational therapy 30 minutes, self care training 15 minutes

Behavioral: Aquatic therapy

Interventions

Aquatic therapyBEHAVIORAL

Children receive aquatic occupational therapy twice a week for 10 weeks. 30 minutes of aquatic therapy in a warm water pool to increase upper extremity function and swim skills; 15 minutes of self care training to increase independence with dressing and showering.

Intervention: aquatic occupational therapy (AquOTic-NM)

Eligibility Criteria

Age3 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • years for the children, 18+ for the parents/guardians.
  • child with neuro-motor diagnosis (CP, hypoxia, etc.)
  • child impairments in upper extremity function
  • child deficits in performance of self care activities

You may not qualify if:

  • compromised airway
  • uncontrolled seizures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erika Kemp

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Conditions

Cerebral PalsyHypoxia, Brain

Interventions

Aquatic Therapy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypoxiaSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HydrotherapyPhysical Therapy ModalitiesTherapeuticsRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Clinical

Study Record Dates

First Submitted

February 3, 2023

First Posted

March 3, 2023

Study Start

January 9, 2023

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

November 30, 2027

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Deidentified data maybe shared with researchers

Locations